Senior Director, Regulatory Affairs Global Regulatory Leader

Location : Palo Alto CA / Miami FL / Princeton NJ onsite

About Summit :

Ivonescimab known as SMT112 is a novel potential first-in-class investigational

bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF.

Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC) with three active Phase III trials :

• HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g. osimertinib).
• HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
• HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summits license territories including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting .

Overview of Role :

The Senior Director of Regulatory Affairs - Global Regulatory Leader is responsible for developing and implementing global strategies to secure IND / CTA approvals for various studies as well as providing regulatory leadership for planning and execution of subsequent global marketing applications for product(s) in the oncology therapeutic area.

Role and Responsibilities :

Leads global regulatory strategies for assigned products / indications through all phases of development. May include doing so in context of development collaborations and / or partnerships.

Continually expands TA knowledge and ensures strategic messaging and content of global regulatory dossiers to include development of tumor landscape assessment to inform evolving development strategy.

Advises management and cross-functional team members of the effect of current or proposed relevant laws regulations guidelines and standards etc.

Key internal leader and driver of regulatory policy and strategy for assigned products

Lead regulatory team in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products

May lead the Labeling Regulatory Team for given product(s) / indication(s)

Proactively anticipates and mitigates regulatory risks

Demonstrates excellent understanding of drug development and leadership behaviors consistent with level

Develops and implements acceleration strategies as appropriate

Accountable for ensuring that corporate goals are met with respect to assigned projects

Acts independently under direction of Vice President of Regulatory Affairs

Based on experience and scientific strengths expands TA knowledge of TA; provides coaching and mentoring for other regulatory members

Will have direct reports and contributes to the performance management for other RA team members

Makes decisions regarding regulatory work processes or operational plans and schedules in order to achieve the program objectives established

May advance the organizations goals by participating and taking leadership roles in professional associations industry and trade groups as appropriate

Follows budget allocations

All other duties as assigned

Experience Education and Specialized Knowledge and Skills :

Bachelors degree in life sciences (pharmacy biology chemistry pharmacology) or related subject; Masters or Doctorate preferred

Minimum of 12 years experience in pharmaceutical regulatory activities with experience as lead regulatory product strategist in two or more major regions in addition to the US such as EU Japan or China

Requires drug development experience in US & EU

Minimum of 5 years of proven experience in a strategic leadership role with strong project management skills

Experience working in a cross-functional environment with multiple stakeholders and influencing cross-functional teams

Experience interfacing with major government regulatory authorities

Strong communication and proactive negotiation skills

Experience developing and implementing successful global regulatory strategies

Attention to detail accuracy and confidentiality

Clear and concise oral and written communication skills

Critical thinking problem solving ability to work independently

Must be able to effectively multi-task and manage time-sensitive and highly confidential documents

Communicate effectively and articulate complex ideas in an easily understandable way

Ability to successfully work in a fast-paced demanding and collaborative environment

Travel up to approximately 5%

The pay range for this role is $238000 to $298000 annually. Actual compensation packages are based on several factors that are unique to each candidate including but not limited to skill set depth of experience certifications and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus stock benefits and / or other applicable variable compensation.

Summit does not accept referrals from employment businesses and / or employment agencies in respect of the vacancies posted on this site. All employment businesses / agencies are required to contact Summits Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.

Required Experience :

Exec

Key Skills

Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills

Employment Type : Full-Time

Department / Functional Area : Regulatory Affairs

Experience : years

Vacancy : 1

Yearly Salary Salary : 238000 - 298000